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NCT05000203
Intervention by Midwife to Address the Fear of Childbirth
NA trial testing Online prenatal specific education in Fear of Childbirth in 214 participants. Completed in 8 May 2023.
1 November 2022
Quick facts
| Lead sponsor | University of Las Palmas de Gran Canaria |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 214 |
| Start date | 1 June 2021 |
| Primary completion | 1 November 2022 |
| Estimated completion | 8 May 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Online prenatal specific education
- Intrapartum specific support
- Prenatal usual education
- Intrapartum usual support
Conditions studied
- Fear of Childbirth — all drugs for Fear of Childbirth →
Sponsor
University of Las Palmas de Gran Canaria
Who can join
18 and older, female only, with Fear of Childbirth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of the research is to implement a specific intervention directed by midwives to address the fear of childbirth in the prenatal and intrapartum periods. The results obtained in the specific intervention group under study will be compared with those of the control group that will follow the usual care. Fear of childbirth is defined as a state of intense anxiety that leads some women to fear childbirth, provoking a response that can influence the course of pregnancy, childbirth, and postpartum, as well as well-being and child development. Beneficial results have been shown in counseling, and prenatal education for childbirth, appropriate therapies to prevent, or at least reduce this suffering and its consequences. These interventions must be specific to see an improvement in symptoms, and must use a combination of various approaches to promote not only a reduction in fear, but a positive birth experience. The population under study will be made up of pregnant women with a fear of childbirth detected in the second trimester of gestation. The sample will be recruited in the area of prenatal diagnosis of the Hospital Materno Infantil of Canarians (HUMIC). The start of the recruitment of participants is expected in June 2021, the online prenatal education intervention in August 2021 and the intrapartum intervention in October 2020. The intervention is expected to end in April 2022. It will be carried out a consecutive sampling until reaching the estimated sample size of 190 participants with fear of severe delivery who will be randomized to one of the two arms of the trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05000203
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Fear of Childbirth
Currently open trials in the same condition.
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- NCT07268027 — Constructivist Prenatal Education Effects · NA · recruiting
- NCT07263750 — Effect of Haptonomy on Prenatal Attachment and Fear of Childbirth in Primiparous Couples · NA · recruiting
- NCT06813547 — Emotional Freedom Techniques and Virtual Reality Application for Fear of Childbirth · NA · recruiting
Other University of Las Palmas de Gran Canaria trials
Trials by the same sponsor.
- NCT04962737 — Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses · NA · not yet recruiting
- NCT06417450 — Usefulness of NESA Microcurrents in the Treatment of Children With Autism Spectrum Disorders · NA · completed
- NCT06134999 — Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation · NA · completed
- NCT06138158 — Improvement of Fear-avoidance Beliefs in Patients With Chronic Low Back Pain · NA · completed
- NCT05800431 — NESA Microcurrents on Quality of Life in Geriatric Patients · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05000203 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Las Palmas de Gran Canaria
- Last refreshed: 18 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05000203.
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